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alexandrabuga replied to the topic Safety Recalls in the forum Introduction to Project Management 6 years, 11 months ago
I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and understand the directions on the label. I think having a problem with labeling on a product especially a device or drug would warrant a recall. The user has to be able to clearly read the label and all of the pertinent information. Here is PDF document of the CDRH Labeling Regulatory Requirements for Medical Devices:
This is what medical device companies should implement for labeling.